Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

rTMS-behandling av spastisitet hos barn med cerebral parese - en RCT

23. september 2026 oppdatert av: Winnie Wan Yee Tso (Dr), The University of Hong Kong

Repeterende transkraniell magnetisk stimulering (rTMS) for behandling av spastisitet hos barn med hemiplegisk cerebral parese – en randomisert kontrollert prøvelse

This RCT aims to investigate the effect of repetitive transcranial magnatic stimulation (rTMS) in treating children with hemiplegoc cerebral palsy. The study will measure any improvement in spasticity after using contra-lesional inhibitory rTMS follow by intensive limb training.

Participants will attend a 10-day rTMS treatment sessions, follow by intensive training of the impaired limb. They will also undergo MRI scans before and after the treatment to investiagte the underlying neurophysiological mechanisms that lead to changes clinically by using TMS as well as MR-DKI. Researchers will compare the intervention group and the sham group to see if rTMS could result in improvement of participants' spasticity.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Cerebral palsy is the most common cause of lifelong physical disability in childhood, with an estimated prevalence of 1.5 per 1000 living biths for primary school-aged children. Spasticity is the most common symptoms in children with cerebral palsy, leading to muscle weakness affecting gross motor functions and causing complications such as pain, contracture and subluzation which will lead to inability to perform activity-based training and subsequently lead to further muscle weakness. Standard therapy with regular physiotherapy and occupational therapy are essential but time-consuming and the effects might not last for longer duration. Patients or caregivers decline medications because of side effects drowsiness while other interventions such as intra-thecal baclofen pump, rhizotomy or surgery are invasive.

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has the ability to modulate excitation of the motor cortex area of the brain. There were past studies suggesting that using contralesional inhibitory rTMS was safe and feasible for patients with paediatric subcortical stroke and seemed to improve hand function in patients with hemiparesis. However, limited studies have been published on the effects of rTMS on improving spasticity in children with cerebral palsy. Hence, the objective of this study is to use low-frequency rTMS to the contra-lesional hemisphere in children with hemiplegic cerebral palsy to investigate if rTMS follow by intensive limb training would improve spasiticity of these children and whether the improvement can be sustained for a longer time. The underlying mechanisms that lead to the changes clinically will also be investigated by TMS and MRI.

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Winnie Wan Yee Tso, MBBS
  • Telefonnummer: +85222554295
  • E-post: wytso@hku.hk

Studer Kontakt Backup

Studiesteder

  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong, 0000
        • Rekruttering
        • Li Ka Shing Faculty of Medicine
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

4 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients aged between 4 years and 18 years
  • Diagnosis of hemiplegia
  • Upper limb spasticity ≥ 1
  • IQ ≥ 50

Exclusion Criteria:

  • Any contra-indications to rTMS
  • Severe spasticity (score of 4 or more in Ashworth scale)
  • Uncontrollable epilepsy
  • History of Botulinum toxin A injection in previous 6 months
  • Upper limb casting in previous 6 months

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Interventional rTMS group

The intervention group will receive 1 Hz active rTMS during treatment, lasting for 20 minutes, follow up by 1.5 hours of motor training.
Enhet: Repetitive Transcranial Magnetic Stimulation

1 Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training.
Sham-komparator: Sham rTMS group

The sham group will not receive any Hz of rTMS during treatment, also lasting for 20 minutes with 1.5 hours of motor training.
Enhet: Sham Repetitive Transcranial Magnetic Stimulation

Sham Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Modified Ashworth Scale
Tidsramme: Baseline, Day 10, 17 of intervention and 2 months post intervention

Clinical measure of spasticity. Scores range from 0 to 4, with a higher score indicate worse in muscle tone
Baseline, Day 10, 17 of intervention and 2 months post intervention
The range of motion scores
Tidsramme: Baseline, Day 10, 17 of intervention and 2 months post intervention

ROM of thumb adduction, wrist dorsal flexion and extension, and elbow dorsal flexion and extension. Patients' range of motion score will be compared to the normative values
Baseline, Day 10, 17 of intervention and 2 months post intervention
The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Tidsramme: Baseline, Day 10, 17 of intervention and 2 months post intervention

The BOT-2 provides a comprehensive overview of fine and gross motor skills in children and young adults within school age-range.
Baseline, Day 10, 17 of intervention and 2 months post intervention

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gross motor function measure
Tidsramme: Baseline, Day 10, 17 of intervention and 2 months post intervention

Changes in motor function. A 4-point Likert scale with higher score indicates better motor function
Baseline, Day 10, 17 of intervention and 2 months post intervention
Pediatric Quality of Life Cerebral Palsy module
Tidsramme: Baseline, Day 10, 17 of intervention and 2 months post intervention

Quality of life measurement. Scores range from 0 to 100 with higher score indicate better quality of life.
Baseline, Day 10, 17 of intervention and 2 months post intervention
MRI Brain: fMRI and DKI
Tidsramme: Baseline, Day 10, 17 of intervention and 2 months post intervention

Functional MRI and Diffusion Kurtosis Imaging measuring the brain microstructural changes and structural connectivity during the intervention
Baseline, Day 10, 17 of intervention and 2 months post intervention
Purdue Pegboard Test
Tidsramme: Baseline, Day 10, 17 of intervention and 2 months post intervention

A standardized evaluation tool used to measure gross movements of hands, fingers, and arms, as well as fine fingertip dexterity.
Baseline, Day 10, 17 of intervention and 2 months post intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The University of Hong Kong

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. januar 2024

Primær fullføring (Antatt)

1. desember 2029

Studiet fullført (Antatt)

1. desember 2029

Datoer for studieregistrering

Først innsendt

7. november 2023

Først innsendt som oppfylte QC-kriteriene

10. november 2023

Først lagt ut (Faktiske)

13. november 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • rTMSCPHKU

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere